Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K923992 |
Device Name |
POWER PACK 350/BATTERY PACK 351 |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Applicant Contact |
DIANE ZOFCHAK |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
186 WOOD AVENUE SOUTH |
ISELIN,
NJ
08830
|
|
Correspondent Contact |
DIANE ZOFCHAK |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 08/10/1992 |
Decision Date | 04/13/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|